Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127139672 | 12713967 | 2 | F | 2015 | 20160913 | 20160905 | 20160915 | EXP | PT-009507513-1608PRT015535 | MERCK | 48.00 | YR | M | Y | 0.00000 | 20160915 | OT | PT | PT |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127139672 | 12713967 | 1 | PS | RIBAVIRIN. | RIBAVIRIN | 1 | Oral | UNK | Y | 20903 | TABLET | ||||||||
| 127139672 | 12713967 | 2 | SS | PEGINTERFERON ALFA-2B | PEGINTERFERON ALFA-2B | 1 | UNK | Y | 0 | SUBCUTANEOUS INJECTION | |||||||||
| 127139672 | 12713967 | 3 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 1 MG/KG/ DAY | 0 | 1 | MG/KG | TABLET | QD | ||||||
| 127139672 | 12713967 | 4 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 15 MG/DAY | 0 | 15 | MG | TABLET | QD | ||||||
| 127139672 | 12713967 | 5 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | INCREASE WAS REQUIRED DUE TO PLATELET DECREASE TO 35,000/MICROLITR | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127139672 | 12713967 | 1 | Hepatitis C |
| 127139672 | 12713967 | 2 | Hepatitis C |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127139672 | 12713967 | HO |
| 127139672 | 12713967 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127139672 | 12713967 | Haematuria | |
| 127139672 | 12713967 | Petechiae | |
| 127139672 | 12713967 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127139672 | 12713967 | 1 | 201502 | 2015 | 0 | |
| 127139672 | 12713967 | 2 | 201502 | 2015 | 0 |